Contents

Introduction

As of data completion the system will run several type of automated checks and indicate the validation status of the data. The data validation status is expressed by a corresponding color status and warning message at all different data levels (e.g. item/question, form, event,...).

Initial Data Completion

When data completion is initiated values are saved and a field can be changed immediately without editing or explanation. The user who is completing the form will be informed by automatic messages displayed on top of the form in case mandatory data is missing and/or in case of outstanding range checks.

Once all mandatory data is completed and there are no outstanding range checks, a message will be displayed that the form is ready for submission.

Specific situation: in case an existing question has been disabled, in the DB design, before submission of the eCRF, the answer is deleted and the question will be locked for editing.

Validation Status

The colors linked to the different data levels (category, event(group), form, itemgroup, item) indicate the validation status of the data. Before submission the data will be displayed as optional, missing or incomplete. In case data is completed, automatic checks will be done by the system at submission of the data which will result in a new validation status: issues or no issues. In case of optional data which is not completed, the status remains optional after submission.

A summary of the validation status is displayed in the general progress on top of the left menu listing the events.

The user can find more details on the validation status by hoovering over the status bar. The number of forms of of the total number of forms per validation status is described in the message displayed.

Data Status

Depending on the study specific design settings the user will have data status options at disposal at any levels from event(group) to item which allow the user to indicate that a certain cycle, visit, assessment or parameter was not done, unknown or not applicable. An icon (examples below) will indicate if such options are available and by clicking the icon the study specific options will be listed. If no data status options are available, the icon will not be displayed for that data level or that parameter.

Example on item level

Example on form level

Format

Several formats are available for data collection and the format is clearly specified in the Clinical Data module.

A warning is shown when a user enters an answer that is not conform to the defined format.

Available formats	Comments
Float	It is possible to enter a comma or a point to enter a float value.
Date	Dates can be entered by: Use of the calendar picker; Or manually entering a date. It is possible to enter ".", "-" or "/" as separator. All separators are converted to a "-" when entering.
Time	It is only possible to enter a ":" as a separator between hours (0-23), minutes (0-59) or seconds (0-59) - ISO standard
Partial date/time completion	For partial dates it is possible to only collect the year or the month and the year. For partial time it is possible to only collect the hour or the hour and minutes. For partial date and time it is possible to collect the date and the hour or the date and the hour and the minutes.
Incomplete date/time completion	For an incomplete date it is possible to define the day, month and/or year as unknown. For an incomplete time it is possible to define the seconds, minutes and/or hours as unknown. For an incomplete date and time it is possible to define the day, month and/or year, the seconds, minutes and/or hours as unknown. The unknown elements in an incomplete date and/or time are entered by an "u" or "-". The "u" or "-" are converted to "unk" when entering.
Questions with predefined labels	Depending on the design settings of the question it is possible to select: 1 label as answer (radio buttons); Multiple labels as an answer (check boxes). In case of disabled labels, it is not possible to (un)select the disabled label as an answer

For each format additional options can be available to indicate if data is unknown, not applicable or not done. A reason has to be provided to confirm the use of such option.

The options not done and not applicable can also be available for a group of questions, a form or for a group of forms/events.

Guidelines and Description

Guidelines	Italic text
Help icon	Descriptive information which becomes available when hoovering over the icon
Information icon	System related information in case of specific formatting requirements

Table View

Data can be displayed in table format to facilitate the overview of data reported. The highlighted row is the data which is expanded below the table format. Data can be modified by clicking on the corresponding row and this expanding the corresponding questions in the regular view.

Prefilled Data

Fields can be prefilled with copied or calculated information. For example the age can be calculated based upon the the birth date. The fields containing prefilled data cannot be edited which is indicated with a lock sign.

Conditional Data

When the user enters certain data this can trigger the appearance of new fields or forms. Such conditional fields or forms will be triggered immediately after completion (prior to submission of the data).

When the completion of conditional data is initiated, but the trigger field is modified and causes the conditional data to become (potentially) obsolete the system raises an inconsistency query. The user is asked to confirm the deletion of this (potential) obsolete data or to confirm to maintain the data, stating a clear reason why.

Data Submission

The submission of data triggers the following processes in the system:

Auto queries are generated on the corresponding eCRF in case of inconsistencies,
The form becomes available for signature when submitted and no issues are discovered.

Options

Form

On each level more or less the same options are available (audit trail, comments, delete and query). In addition the form header will summarize following properties:

Submission status
Signed status
Ownership of the form

Audit Trail

The user can access the audit trail via the button. The audit trail will display all actions performed on any data up to that specific level.

Comments

The comment button will display the number of comments already added on that specific level. If you click it, the display will show those comments.

To add a comment, click the comment button and subsequently select '+ New Comment'. To edit a comment, the user needs to select that specific comment and a pop-up screen will allow the user to update the original comment. A comment can also be deleted with the delete button (X) at the end of the comment row.

Comments can be created by all users with management rights on the eCRFs, meaning for regular CRFs this would be both the site and sponsor.

Delete

A user can choose to remove the form data. When removing data, a reason has to be provided.

ItemGroup

On ItemGroup level a user can access the audit trail, view or add comments and opt to delete the ItemGroup data.

Item

On item level a user can access the audit trail, view or add comments and opt to edit the data.

Edit Data

After submission the data can still be modified or cleared, but the system will request a reason.

Specific situations:

In case a new question was added to the design of the eCRF after submission of such eCRF, it will appear on the submitted eCRF and can be completed without documenting a reason.
In case an existing question has been disabled after submission of the eCRF, the field will be locked for editing and any outstanding queries will be closed automatically.

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